A trial looking at cisplatin, gemcitabine and sunitinib for advanced transitional cell cancer of the urinary system (SUCCINCT)

This trial is looking at a drug called sunitinib with chemotherapy for transitional cell cancer that started in the lining of the bladder, the pelvis of the kidney, or the tube that links the two (the ureter). The trial is for people whose cancer is locally advanced or has spread to another part of their body.

The lining of the urinary system is called the urothelium. It is made up of cells called transitional cells. Cancer that starts in these cells is called transitional cell cancer or ‘transitional carcinoma of the urothelium’.

If transitional cell cancer is locally advanced or has spread to another part of the body, you may have chemotherapy. A combination of the drugs cisplatin and gemcitabine is a standard treatment in this situation. It is known as GC chemotherapy.

Sunitinib is a drug called a tyrosine kinase inhibitor. In this trial, researchers are looking at adding sunitinib to chemotherapy.

The aims of the trial are to

Find out if this combination of drugs helps people with transitional cell cancer of the urinary system
Learn more about the side effects

Recruitment

Start 20/07/2009

End 31/07/2013

Phase

Phase 2

Who can enter

You can enter this trial if you

Have transitional cell cancer of the bladder, ureter or pelvis of the kidney that has spread into surrounding body tissue or to another part of the body
Have cancer that can be seen on scans or X-rays and your doctors don’t think they can cure it with surgery or radiotherapy
Are well enough to take part in the trial (performance status of 0, 1 or 2)
Have satisfactory blood test results
Are willing to use reliable contraception during the trial and for a year afterwards if there is any chance you or your partner could become pregnant
Are at least 16 years old

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord (central nervous system)
Have already had drug treatment for cancer that has spread - you can take part if you had chemotherapy before or after surgery to try to stop the cancer coming back or spreading, as long it finished at least 6 months ago
Have had radiotherapy in the last month, or earlier if it was to more than a third of your bone marrow (you can ask your doctor about this)
Have had an experimental drug as part of another clinical trial in the last month
Have had any other cancer apart from non melanoma skin cancer, carcinoma in situ of the cervix or prostate cancer contained within the prostate gland
Have high blood pressure that cannot be controlled with medication
Have had a heart attack in the last 6 months or have other heart problems that are a cause for concern
Have an infection
Are having drugs such as warfarin to prevent or treat blood clots
Take any other medication that could interact with sunitinib (you can ask your doctor about this)
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit about 63 people in the UK.

Everybody taking part will have cisplatin, gemcitabine and sunitinib in 3 week cycles of treatment. On day 1 of each cycle you have cisplatin, gemcitabine and some extra fluids through a drip into a vein. This will take quite a few hours each time. On day 8 you have just gemcitabine through a drip which takes about half an hour. And you take sunitinib capsules once a day on days 2 to 15. You may have up to 6 cycles of treatment, lasting about 4 months.

The researchers may ask your permission to take extra blood samples and to get a sample of cancer tissue taken when you had surgery or a biopsy. They will study these samples to learn more about this type of cancer and how the treatment works. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

Before you start treatment, you will see the trial doctors and have some tests. The tests include

Physical examination
Blood tests
Chest X-ray
CT scan
Heart trace (ECG)
Bone scan (if your doctor thinks your cancer might have spread to your bones)

During the trial, you go to hospital once a week for up to 18 weeks. You may be able to have all the treatment as an outpatient. But you might have to stay in hospital overnight on day 1 of each treatment cycle.

You have CT scans before the 4th cycle of treatment and at the end of treatment. After you finish treatment, you will see the doctors and have more scans and blood tests at 6 months and one year.

Side effects

The side effects of gemcitabine and cisplatin (GC) include

Sickness
Changes to your digestive system
Tiredness (fatigue)
A drop in the number of blood cells causing an increased risk of infection, tiredness, shortness of breath, bruising and bleeding problems
Sore mouth
Loss of appetite and taste changes
Weight loss
Hair loss
Kidney damage
Skin rash
Fever

The side effects of sunitinib may include

High blood pressure
Skin rash or blistering on the hands or feet
Temporary changes to the colour of the skin

You must not eat grapefruit (or drink the juice) during this trial as it can interact with sunitinib. And you should not take St John’s wort during the trial.

There is more information about the side effects of GC and sunitinib on CancerHelp UK.